GBI Biomanufacturing has announced manufacturing partnership with Allterum Therapeutics to advance Allterum's lead candidate 4A10 into clinic. 

4A10 is a monoclonal antibody (mAb) targeting CD127, a receptor expressed by a broad variety of cancers. 

With this collaboration, GBI will leverage their extensive expertise in manufacturing complex biologics to ensure the high-quality production of 4A10 for Phase 1/2a clinical trials. 

Allterum's initial trial will focus on patients who have acute lymphoblastic leukemia (ALL), with subsequent expansion to trials in patients with other CD127-expressing hematological malignancies, including lymphomas and acute myeloid leukemia.

"We are honored to be chosen by Allterum as their trusted partner on this important project. Our team is dedicated to providing the highest quality development and manufacturing services for drug substances and drug products, ensuring the success of this promising treatment. This collaboration is a testament to our commitment to advancing the field of oncology and making a meaningful difference in the lives of patients," said Karl Pinto, Chairman and CEO of GBI.

Atul Varadhachary, Allterum's CEO and Managing Partner at Fannin added, "4A10 has demonstrated robust preclinical activity across multiple cancers and we are excited about advancing it into the clinic. We selected GBI as our manufacturing partner based on their years of experience with complex biologics, and we look forward to working together to ensure our program's success." 

Allterum's 4A10 development program is supported by grant funding from the Cancer Prevention and Research Institute of Texas (CPRIT), and the National Cancer Institute (NCI) and additionally has been supported through the NCI Experimental Therapeutics Program (NExT).

The antibody, invented at the NCI by senior investigator Scott Durum, PhD and his collaborators, is licensed exclusively to Allterum. Allterum has received Orphan Drug and Rare Pediatric Disease designations for ALL from the FDA, which will provide facilitated access to the FDA and potentially qualify 4A10 for a Pediatric Priority Review Voucher.

Successful completion of Allterum's Phase 1/2a clinical trials will mark a significant milestone in developing this promising anti-cancer drug, addressing major unmet medical needs.